Trials / Recruiting
RecruitingNCT07071623
A Study of MK-8527 to Prevent Human Immunodeficiency Virus Type 1 (HIV-1) (MK-8527-010)
A Phase 3, Randomized, Active-Controlled, Double-Blind Clinical Study to Evaluate the Efficacy and Safety of MK-8527 Oral Once-Monthly as HIV-1 Preexposure Prophylaxis in Women
- Status
- Recruiting
- Phase
- Phase 3
- Study type
- Interventional
- Enrollment
- 4,580 (estimated)
- Sponsor
- Merck Sharp & Dohme LLC · Industry
- Sex
- Female
- Age
- 16 Years – 30 Years
- Healthy volunteers
- Accepted
Summary
Researchers are looking for new medicines to prevent HIV-1 (Human Immunodeficiency Virus Type 1) infection. The goals of this study are to learn: * If taking MK-8527 once a month works to prevent HIV-1 infection better than a standard (usual) pre-exposure prophylaxis (PrEP) taken once a day * About the safety of MK-8527 and if people tolerate it
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | MK-8527 | Oral tablet |
| DRUG | Emtricitabine/tenofovir disoproxil (FTC/TDF) | Oral tablet |
| DRUG | Placebo matched to MK-8527 | Placebo oral tablet matched to MK-8527 |
| DRUG | Placebo matched to FTC/TDF | Placebo oral tablet matched to FTC/TDF |
Timeline
- Start date
- 2025-11-10
- Primary completion
- 2027-10-18
- Completion
- 2027-10-18
- First posted
- 2025-07-17
- Last updated
- 2026-03-30
Locations
29 sites across 3 countries: Kenya, South Africa, Uganda
Regulatory
- FDA-regulated drug study
Source: ClinicalTrials.gov record NCT07071623. Inclusion in this directory is not an endorsement.